Of the estimated 19 million North American adults who have urinary incontinence, 20% are estimated to be men. Such condition can range in severity from partial to complete loss of bladder control and patients afflicted with urinary incontinence can experience varying degrees of urine loss. In addition, it is known that urinary incontinence may change over time and that men and women with light incontinence, for example, may experience minimal leakage during the occurrence of a provocative event, such as laughing or coughing, whereas men with heavy incontinence may experience continuous urine leakage.
Generally, urinary incontinence is not considered a disease, but rather a symptom or side effect of another medical condition. Some conditions known to cause male urinary incontinence include prostate surgery, and in particular total prostatectomy, head and spinal cord injury, infection, certain toxins, such as too much alcohol consumption, certain medications, such as sedating medications, and certain diseases, such as cancer, Parkinson's disease and multiple sclerosis. Indeed, male incontinence can be caused simply by virtue of the aging process or emotional distress.
Each case of incontinence, however, is unique and no two people are affected by incontinence in the same way. There are, however, well-recognized types of incontinence and various ways to treat the same. Stress incontinence, which is a common type of incontinence, may be characterized as urine leakage during a provocative event such as sneezing, laughing, lifting heavy objects, or when the patient engages in any type of exercise that puts pressure on the bladder. Urge incontinence occurs when the patient wants to urinate but is incapable of exercising restraint until reaching a restroom. Additional types of incontinence include overflow incontinence, which occurs when the quantity of urine exceeds the capacity of the patient's bladder, and functional incontinence, which occurs when the patient has knowledge of the need to urinate but simply cannot access a restroom quickly enough due to a physical obstruction or debilitation.
To treat urinary incontinence, several options are available. Among the more effective types of recognized treatment include behavioral techniques, such as biofeedback, bladder training, and pelvic muscle exercises, and modifications of the patient's diet and fluid intake. With respect to the latter, it is known that eliminating or cutting back on certain types of substances, such as caffeine and alcohol, can help alleviate incontinence. There are additionally medications available, such as dicyclomine (Bentyl), flavoxate (Urispas), hyoscyamine sulfate (Anaspaz), imipramine (Tofranil), oxybutynin (Ditropan), tolterodine (Detrol), and propantheline (Pro-Banthine), phenylpropanolamine (Dexatrim), and pseudoephedrine (Sudafed) that are helpful in controlling urinary incontinence.
Surgery may additionally be an option to treat male urinary incontinence. Along these lines, surgically implantable devices for males, such as the In-Vance sling device and Artificial Urinary Sphincter (AUS), produced by American Medical Systems, Inc., of Minneapolis, Minn. The InVance sling device is a commercially available surgically implantable device that is operative to provide structural support to the urethra for the treatment of stress incontinence. In this regard, the device is operative to provide structural support to the urethra such that during a provocative event, the device will provide structural support to the urethra thus causing the urine to be retained within the bladder and not leak through the urethra. The AUS is a fluid-filled cuff that surrounds the urethra and keeps it closed. While both devices have been used in the treatment of incontinence, they are not easily used by the average urologist. For example, there are issues with the patient not being 100% dry postoperatively due to the sling or AUS being too loose. Alternatively, there are also issues with patients being put in retention postoperatively due to the device being too tight.
Utilizing such sling devices to treat incontinence has been known to have numerous additional drawbacks. For example, securing suburethral sling devices into position typically requires the use of bone screws, which are well-known in the art to be difficult and time consuming to deploy, and can result in significant patient discomfort, especially within the first couple of weeks following the surgical implantation.
In addition, procedures and methods for implanting suburethral sling devices often lead to difficulties in securing them into position with optimal degrees of tension. Indeed, the implantation of suburethral sling devices for the treatment of incontinence may be complex and time consuming, and may produce suboptimal clinical outcomes. Moreover it is recognized among surgeons who perform such implant procedures that sutures attached to bone anchors or bone screws, which are utilized to secure the devices into position, frequently break and that often times additional bone anchors or screws must be secured into position. In fact, sutures attached to bone anchors and or bone screws usually need to be individually re-tensioned several times before optimal device positioning and structural support to the urethra is achieved.
Accordingly, there is a substantial need in the art for a suburethral implantable device for the treatment of incontinence that may be easier to surgically secure into position and that may further provide an optimal degree of urethral support to thus effectively treat urinary incontinence. There is additionally a need in the art for an implantable device that may be simply constructed, easy to surgically manipulate, and which may be manufactured at relatively low cost utilizing known implant materials—whether they are synthetic materials, natural tissues, or combinations thereof. There is yet a further need in the art for such an implantable device that can be secured into position such that the device defines a suburethral portion operatively positioned to support the bulbar urethral region of the patient, with the device remaining in position via use of at least a pair of elongated extension members, such as arms, that are secured at or near respective pubic rami (variously referred to in the art as pubic rami/ramus (plural/singular) or descending pubic rami/ramus (plural/singular)—which surround or define the obturator foramen of a patient's pelvic region) without the use of bone anchors. With respect to the latter, it would be advantageous for such an implantable device to be secured, at least in part, by way of obturator foramen and preferably via pubic rami thereof. There is also a need for an implantable device that provides an opportunity to adjust tensioning of the implanted device postoperatively, in a minimally invasive and efficient manner.